Skip to main content
OpenTrials
Completed

NCT Number: NCT02933580

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-56136379 in Healthy Japanese Adult Participants

The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of JNJ-56136379 in healthy Japanese adult participants following oral administration of single doses from 25 milligram (mg) up to 600 mg, in fasted conditions.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Glendale, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant must be a Japanese participant who has resided outside Japan for no more than 10 years and whose parents and grandparents are Japanese as determined by participant's verbal report
  • Participant must be healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical and surgical history, vital signs, and the results of blood biochemistry, blood coagulation, and hematology tests and a urinalysis performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed/signed by the investigator
  • Participant must have a body mass index (BMI; weight in kilogram [kg] divided by the square of height in meters) of 18.0 to 30.0 kilogram per meter square [kg/m^2], extremes inclusive, and body weight not less than 45.0 kg
  • Participant must have a normal 12-lead electrocardiogram (ECG) (based on the mean value of the triplicate parameters) at screening including: normal sinus rhythm (heart rate between 45 and 100 beats per minute [bpm], extremes included); QT interval corrected for heart rate according to Fridericia (QTcF) less than or equal to (<=)450 millisecond (ms); QRS interval less than (<)120 ms; PR interval <=220 ms
  • A female participant (except if permanently sterile), should have a negative serum pregnancy test at screening and all female participants should have a negative urine pregnancy test on Day -1

Exclusion criteria

  • Participant with a past history of cardiac arrhythmias (example [eg], extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome)
  • Female participant who is breastfeeding at screening or pregnant at screening or predose
  • Male participant planning to father a child while enrolled in this study or within 90 days after study drug administration
  • Participant with current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at Screening
  • Participant with current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M [IgM]), or hepatitis B virus (HBV) infection (confirmed by HBsAg), or hepatitis C virus (HCV) infection (confirmed by HCV antibody), or hepatitis E infection (confirmed by hepatitis E antibody IgM) at Screening

Treatment and study plan

JNJ-56136379

Drug

Participants will receive a single oral dose (tablets) of JNJ-56136379 on Day 1.

Placebo

Other

Participants will receive matching placebo tablets on Day 1.

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Up to 29 days

    The Cmax is the maximum observed plasma concentration.

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: Up to 29 days

    The Tmax is defined as actual sampling time to reach maximum observed plasma analyte concentration.

  3. Area Under the Concentration-Time Curve from time 0 to the Time of the Last Measurable non-Below Quantification Limit Concentration (AUC [0-last])

    Time frame: Up to 29 days

    AUC (0-last) is defined as area under the analyte concentration-time curve from time 0 to the time of the last measurable (non-below quantification limit [BQL]) concentration, calculated by linear-linear trapezoidal summation.

  4. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])

    Time frame: Up to 29 days

    The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last observed measurable (non-BQL) concentration, and lambda(z) is elimination rate constant; extrapolations of more than 20.00 percent (%) of the total AUC are reported as approximations.

  5. Number of Participants With Adverse events as a Measure of Safety and Tolerability

    Time frame: 30-35 days after study drug intake (approximately 8 weeks)

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Double-blind, Placebo-controlled, Randomized, Phase 1, Single Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-56136379 in Healthy Japanese Adult Subjects

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 14, 2016
Registry last updated
Mar 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.